Agency Forms Undergoing Paperwork Reduction Act Review, 31380-31381 [2015-13385]
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31380
Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
and (6), Title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Development and validation of
laboratory procedures using next
generation sequencing technologies to
assess genes causing severe combined
immune deficiency (SCID) in state
newborn screening laboratories’’, EH15–
002.
Contact Person for More Information:
Jane Suen, Dr.P.H., M.S., Scientific
Review Officer, CDC, 4770 Buford
Highway, NE., Mailstop F63, Atlanta,
Georgia 30341–3724, Telephone (770)
488–4281.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Proposed Project
Birth Defects Study To Evaluate
Pregnancy exposureS (BD–STEPS)
(formerly titled The National Birth
Defects Prevention Study (NBDPS)),
(OMB 0920–0010, Expiration 01/31/
2017)—Revision—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
[FR Doc. 2015–13314 Filed 6–1–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–0010]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
VerDate Sep<11>2014
17:26 Jun 01, 2015
Jkt 235001
Background and Brief Description
CDC has been monitoring the
occurrence of serious birth defects and
genetic diseases in Atlanta since 1967
through the Metropolitan Atlanta
Congenital Defects Program (MACDP).
The MACDP is a population-based
surveillance system for birth defects
currently covering three counties in
Metropolitan Atlanta.
Since 1997, CDC has funded casecontrol studies of major birth defects
that utilize existing birth defect
surveillance registries (including
MACDP) to identify cases and study
birth defects causes in participating
states/municipalities across the United
States.
The current study, BD–STEPS, is a
case-control study that is similar to the
previous CDC-funded birth defects casecontrol study, NBDPS, which stopped
interviewing participants in 2013. As
with NBDPS, BD–STEPS control infants
are randomly selected from birth
certificates or birth hospital records;
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
mothers of case and control infants are
interviewed using a computer-assisted
telephone interview.
The results from NBDPS have
improved understanding of the causes
of birth defects. Over 200 articles have
been written in professional journals
using the data from NBDPS, and BD–
STEPS data will soon be added to
NBDPS data for analysis. The current
BD–STEPS revision is a change in
proposed data collection. Specifically,
the study will not ask BD–STEPS
participants to participate in saliva
collection as originally planned, but we
will add an opportunity for some
participants to respond to an online
questionnaire, and we will also ask
some participants for permission to
retrieve newborn bloodspots.
The BD–STEPS interview takes
approximately forty-five minutes to
complete. A maximum of 275
interviews are planned per year per
center, 200 cases and 75 controls. With
seven centers planned, the maximum
interview burden for all centers
combined would be approximately
1,444 hours. Mothers in five of the
seven BD–STEPS Centers will also be
asked to provide consent for the study
to access previously collected infant
bloodspots. It takes approximately 15
minutes to read, sign and return the
informed consent for retrieval of
bloodspots. For approximately one fifth
of participants, some medical records
review will be conducted. The medical
records release form will take
participants approximately 15 minutes
to read, sign and return. In addition, it
will take approximately 30 minutes for
each medical record reviewer to
conduct the review and send the
medical record. Finally, the newly
planned online questionnaire will be
offered to approximately one third of
participants who report certain
occupations during the telephone
interview; these participants will be
asked to complete additional
occupational questions via a Web site
which will take approximately 20
minutes to answer.
Information gathered from both the
interviews and the Deoxyribonucleic
acid specimens has been and will
continue to be used to study
independent genetic and environmental
factors as well as gene-environment
interactions for a broad range of
carefully classified birth defects.
This request is submitted to revise the
previously estimated burden details and
to request OMB clearance for three
additional years. The total estimated
annual burden hours are 2,290.
There are no costs to the respondents
other than their time.
E:\FR\FM\02JNN1.SGM
02JNN1
31381
Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Activity
Mothers (interview) .........................................
Telephone consent and BD–STEPS questionnaire.
Written consent for bloodspot retrieval ..........
Online Occupational Questionnaire ...............
Written release for medical records review ...
Pulling and sending records ..........................
Mothers (consent for bloodspot retrieval) .......
Mothers (online occupational questionnaire) ..
Mothers (consent for medical records review)
Records reviewers (medical records review)
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–13385 Filed 6–1–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Advisory Committee on Immunization
Practices
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC) announce
the following federal advisory
committee meeting.
Times and dates:
8:00 a.m.–5:15 p.m., June 24, 2015
8:30 a.m.–3:30 p.m., June 25, 2015
Place: CDC, Tom Harkin Global
Communications Center, 1600 Clifton
Road NE., Building 19, Kent ‘‘Oz’’
Nelson Auditorium, Atlanta, Georgia
30333
Status: Open to the public, limited
only by the space available. Time will
be available for public comment. The
public is welcome to submit written
comments in advance of the meeting.
Comments should be submitted in
writing by email to the contact person
listed below. The deadline for receipt is
June 22, 2015. All requests must contain
the name, address, and organizational
affiliation of the speaker, as well as the
topic being addressed. Written
comments should not exceed one singlespaced typed page in length and
delivered in three minutes or less.
Please note that the public comment
period may end before the time
indicated, following the last call for
comments. Members of the public who
wish to provide public comments
should plan to attend the public
comment session at the start time listed.
Written comments received in advance
VerDate Sep<11>2014
17:26 Jun 01, 2015
Jkt 235001
of the meeting will be included in the
official record of the meeting.
The meeting will be webcast live via
the World Wide Web; for instructions
and more information on ACIP please
visit the ACIP Web site: https://
www.cdc.gov/vaccines/acip/
Purpose: The committee is charged
with advising the Director, CDC, on the
appropriate use of immunizing agents.
In addition, under 42 U.S.C. 1396s, the
committee is mandated to establish and
periodically review and, as appropriate,
revise the list of vaccines for
administration to vaccine-eligible
children through the Vaccines for
Children (VFC) program, along with
schedules regarding the appropriate
periodicity, dosage, and
contraindications applicable to the
vaccines. Further, under provisions of
the Affordable Care Act, at section 2713
of the Public Health Service Act,
immunization recommendations of the
ACIP that have been adopted by the
Director of the Centers for Disease
Control and Prevention must be covered
by applicable health plans.
Matters for discussion: The agenda
will include discussions on:
Meningococcal vaccines; general
recommendations; human
papillomavirus vaccines; influenza;
influenza A(H5N1) vaccine, tetanus,
diphtheria, and acellular pertussis
(Tdap) vaccine; combination vaccines;
smallpox vaccine in laboratory
personnel; pneumococcal vaccines;
child/adolescent immunization
schedule; herpes zoster vaccines;
Japanese encephalitis vaccine and
vaccine supply. Recommendation votes
are scheduled for meningococcal
vaccines, influenza, influenza A (H5N1),
smallpox vaccine in laboratory
personnel, general recommendations
and pneumococcal vaccines. A Vaccines
for Children (VCF) vote is scheduled for
meningococcal vaccines.
Agenda items are subject to change as
priorities dictate.
Contact person for more information:
Stephanie Thomas, National Center for
Immunization and Respiratory Diseases,
CDC, 1600 Clifton Road NE., MS–A27,
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
1,925
1
45/60
1,375
642
385
385
1
1
1
1
15/60
20/60
15/60
30/60
Atlanta, Georgia 30333, telephone 404/
639–8836; Email ACIP@CDC.GOV
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–13312 Filed 6–1–15; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting for the initial
review of applications in response to PA
07–318, NIOSH Member Conflict
Review.
Time and date: 1:00 p.m.–4:00 p.m.,
EST, June 25, 2015 (Closed)
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in section 552b(c)
(4) and (6), Title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘NIOSH Member Conflict PA 07–318.’’
Contact person for more information:
Nina Turner, Ph.D., Scientific Review
E:\FR\FM\02JNN1.SGM
02JNN1
]]>Agencies
[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31380-31381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13385]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-0010]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS)
(formerly titled The National Birth Defects Prevention Study (NBDPS)),
(OMB 0920-0010, Expiration 01/31/2017)--Revision--National Center on
Birth Defects and Developmental Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC has been monitoring the occurrence of serious birth defects and
genetic diseases in Atlanta since 1967 through the Metropolitan Atlanta
Congenital Defects Program (MACDP). The MACDP is a population-based
surveillance system for birth defects currently covering three counties
in Metropolitan Atlanta.
Since 1997, CDC has funded case-control studies of major birth
defects that utilize existing birth defect surveillance registries
(including MACDP) to identify cases and study birth defects causes in
participating states/municipalities across the United States.
The current study, BD-STEPS, is a case-control study that is
similar to the previous CDC-funded birth defects case-control study,
NBDPS, which stopped interviewing participants in 2013. As with NBDPS,
BD-STEPS control infants are randomly selected from birth certificates
or birth hospital records; mothers of case and control infants are
interviewed using a computer-assisted telephone interview.
The results from NBDPS have improved understanding of the causes of
birth defects. Over 200 articles have been written in professional
journals using the data from NBDPS, and BD-STEPS data will soon be
added to NBDPS data for analysis. The current BD-STEPS revision is a
change in proposed data collection. Specifically, the study will not
ask BD-STEPS participants to participate in saliva collection as
originally planned, but we will add an opportunity for some
participants to respond to an online questionnaire, and we will also
ask some participants for permission to retrieve newborn bloodspots.
The BD-STEPS interview takes approximately forty-five minutes to
complete. A maximum of 275 interviews are planned per year per center,
200 cases and 75 controls. With seven centers planned, the maximum
interview burden for all centers combined would be approximately 1,444
hours. Mothers in five of the seven BD-STEPS Centers will also be asked
to provide consent for the study to access previously collected infant
bloodspots. It takes approximately 15 minutes to read, sign and return
the informed consent for retrieval of bloodspots. For approximately one
fifth of participants, some medical records review will be conducted.
The medical records release form will take participants approximately
15 minutes to read, sign and return. In addition, it will take
approximately 30 minutes for each medical record reviewer to conduct
the review and send the medical record. Finally, the newly planned
online questionnaire will be offered to approximately one third of
participants who report certain occupations during the telephone
interview; these participants will be asked to complete additional
occupational questions via a Web site which will take approximately 20
minutes to answer.
Information gathered from both the interviews and the
Deoxyribonucleic acid specimens has been and will continue to be used
to study independent genetic and environmental factors as well as gene-
environment interactions for a broad range of carefully classified
birth defects.
This request is submitted to revise the previously estimated burden
details and to request OMB clearance for three additional years. The
total estimated annual burden hours are 2,290.
There are no costs to the respondents other than their time.
[[Page 31381]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Respondents Activity respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Mothers (interview)................... Telephone consent and BD- 1,925 1 45/60
STEPS questionnaire.
Mothers (consent for bloodspot Written consent for 1,375 1 15/60
retrieval). bloodspot retrieval.
Mothers (online occupational Online Occupational 642 1 20/60
questionnaire). Questionnaire.
Mothers (consent for medical records Written release for 385 1 15/60
review). medical records review.
Records reviewers (medical records Pulling and sending 385 1 30/60
review). records.
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-13385 Filed 6-1-15; 8:45 am]
BILLING CODE 4163-18-P
